DILTIAZEM HYDROCHLORIDE capsule, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

DILTIAZEM HYDROCHLORIDE (UNII: OLH94387TE) (DILTIAZEM - UNII:EE92BBP03H)

Saatavilla:

PuraCap Laboratories LLC dba Blu Pharmaceuticals

INN (Kansainvälinen yleisnimi):

DILTIAZEM HYDROCHLORIDE

Koostumus:

DILTIAZEM HYDROCHLORIDE 120 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications. Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) are indicated for the treatment of chronic stable angina. Diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Tuoteyhteenveto:

Diltiazem Hydrochloride Extended-Release Capsules USP (Once-a-Day Dosage) Strength Description Quantity NDC # 120 mg Pink opaque hard gelatin capsule black impritned “ Andrx 696” and “120 mg” containing white to off-white round pellets 30’s 90’s 24658-341-30 24658-341-90 180 mg Buff opaque/light blue opaque hard gelatin capsule black imprinted “ Andrx 697” and”180 mg” containing white to off-white round pellets 30’s 90’s 24658-342-30 24658-342-90 240 mg Light blue/pink opaque hard gelatin capsule black imprinted “ Andrx 698” and “240 mg” containing white to off-white round pellets 30’s 90’s 24658-343-30 24658-343-90 300 mg Buff opaque/pink opaque hard gelatin capsule black imprinted “ Andrx 699” and “300 mg” containing white to off-white round pellets 30’s 90’s 24658-344-30 24658-344-90 360 mg Light blue opaque hard gelatin capsules black imprinted “ Andrx 700” and “360 mg” containing white to off-white round pellets 30’s 90’s 24658-345-30 24658-345-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid excessive humidity. Dispense in tight containers with safety closures. Distributed by: PuraCap Laboratories, LLC DBA Blu Pharmaceuticals Franklin, KY 42134 USA 1-877-264-0258 Revised: March 2017 341032017

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DILTIAZEM HYDROCHLORIDE- DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED
RELEASE
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
----------
DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE CAPSULES USP (ONCE-A-DAY
DOSAGE)
DESCRIPTION
Diltiazem hydrochloride is a calcium ion cellular influx inhibitor
(slow channel blocker or calcium
antagonist). Chemically, diltiazem hydrochloride is
1,5-benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-
(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-,
monohydrochloride, (+)-cis-. The chemical
structure is:
Diltiazem hydrochloride is a white to off-white crystalline powder
with a bitter taste. It is soluble in
water, methanol and chloroform and has a molecular weight of 450.98.
Its molecular formula is C
H
N
O
S•HCl. Diltiazem Hydrochloride Extended-Release Capsules USP
(Once-a-Day Dosage)
contain diltiazem hydrochloride in extended-release pellets at doses
of 120, 180, 240, 300 and 360 mg.
Diltiazem Hydrochloride Extended-release Capsules USP (Once-a-Day
Dosage) also contain: black
iron oxide, corn starch, ethylcellulose, D&C Yellow #10 Aluminum Lake,
FD&C Blue #1 Aluminum
Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin,
hypromellose 2910,
magnesium stearate, nonoxynol 100, pharmaceutical glaze, polysorbate
80, polyacrylic dispersion,
povidone, propylene glycol, sucrose, talc and titanium dioxide. The
120 mg capsules also contain: D&C
Red #28, FD&C Blue #1 and FD&C Red #40. The 180 mg capsules also
contain: D&C Yellow #10,
FD&C Blue #1 and FD&C Yellow #6. The 240 mg capsules also contain: D&C
Red #28, FD&C Blue
#1 and FD&C Red #40. The 300 mg capsules also contain: D&C Red #28,
D&C Yellow #10, FD&C
Blue #1, FD&C Red #40 and FD&C Yellow #6. The 360 mg capsules also
contain: FD&C Blue #1.
For oral administration.
Meets USP requirements for dissolution test 15.
CLINICAL PHARMACOLOGY
The therapeutic effects of diltiazem hydrochloride are believed to be
related to its ability to inhibit the
cellular influx of calcium ions during membrane depolarization of
cardiac and vasc